MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP UNI FEMORAL SZ6 LM/RL; EARLY INTERVENTION : KNEE FEMORAL

Catalog Number	102407600
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	05/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient has presented with a painful joint.Preoperative bone scans show increased uptake around the femoral component (hot).This appears to indicate a loose femoral component.On opening the knee surgeon found the medial facet of the unresurfaced patella to show evidence of cartilage wear due to articulation on the lateral edge of the femoral component.The femoral component was not overtly loose, but with gentle persuasion, the femoral component came away from the femur.It was believed that both the "loose" femur and the patella wear was the source of the pain.The femoral component was replaced with new one and the medial facet of the patella respected to reduce chance of impingement.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : product code 102407600, lot number b1net4000.Device history review: dhr reviewed.Nr associated with record has nothing that would correlate to complaint.Nr reviewed by quality engineer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA HP UNI FEMORAL SZ6 LM/RL
• Common Device Name: EARLY INTERVENTION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7613740
• Report Number: 1818910-2018-62592
• Device Sequence Number: 2073884
• Product Code: HRY
• UDI-Device Identifier: 10603295001768
• UDI-Public: 10603295001768
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 102407600
• Device Lot Number: B1NET4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR